Method and apparatus for magnetic induction therapy

ABSTRACT

An energy emitting apparatus for providing a medical therapy includes one or more energy generators, a logic controller electrically connected to the one or more energy generators, and one or more sensors for detecting electric conduction in a target nerve that are connected to the logic controller. The one or more energy generators produce energy focused on the target nerve upon receiving a signal from the logic controller, and the energy is varied by the logic controller according to an input provided by the one or more sensors. In one embodiment, the energy emitting apparatus is an apparatus for magnetic induction therapy that includes one or more conductive coils disposed in an ergonomic housing that produce a magnetic field focused on the target nerve upon receiving an electric current from the logic controller based on an input provided by the one or more sensors.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/866,329 filed Oct. 2, 2007, which claims priority to U.S. ProvisionalPatent Application No. 60/848,720 filed Oct. 2, 2006, the contents ofwhich are incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to energy emitting apparatus and methodsfor providing a medical therapy. In one embodiment, the energy emittingapparatus is an ergonomic wrap or cradle that contains conductive coilsgenerating a magnetic field directed to a target nerve.

BACKGROUND OF THE INVENTION

Overactive bladder (“OAB”) and urinary incontinence (“UI”) affect over16% of the American population each year, or approximately 34 millionmen and women. Outside of the United States, OAB and UI affects over 46million Europeans. The economic cost of OAB and UI is estimated to be inexcess of $12 billion a year in the United States alone.

Due to the social stigmas attached to OAB and UI and tomisunderstandings related to the symptoms associated with OAB and UI,only 40% of the affected individuals in the United States seek medicaltreatment. Of those 13.6 million Americans seeking medical treatment,nearly 30% or 4 million individuals are reportedly unsatisfied withtheir current therapy.

Known treatments for OAB and UI include exercise and behavioralmodifications, pharmacological therapies, surgical intervention andneuromodulation, but each of these treatments exhibits severelimitations.

Exercise and behavioral modifications often require patients to adhereto stringent routines, including scheduled voiding, maintenance of abladder diary, and intense exercise regimens. While this type oftreatment may be a viable option for a small group of highly dedicatedindividuals, its daily impact on a person's life makes it unattractivefor most patients.

Pharmacological intervention is the most widely prescribed therapy forOAB and UI. Unfortunately, patients often suffer from side effectsrelated to their drug therapies. Such side effects are sometimes seriousand are particularly pronounced in elderly patient populations that tendto use a plurality of medications. In addition, approximately 30% of allpatients subjected to pharmacological therapies appear to bedissatisfied with the efficacy of their prescribed treatments.

Surgical intervention IS extremely invasive and often results in along-term requirement for catheterization that may become permanent insome instances. The negative impact of these procedures on the patient'squality of life and their high expense make surgical intervention arecommended option only when all other treatment options have beenexhausted.

Neuromodulation is another available therapy for OAB and UI. In general,pulsed electromagnetic stimulation (“PES”) has proven to have beneficialeffects in a variety of medical applications. The related scientificprinciple is that an electric current passing through a coil generatesan electromagnetic field, which induces a current within a conductivematerial placed inside the electromagnetic field.

More particularly, PES has been shown to be an effective method ofstimulating a nerve positioned within the electromagnetic field, therebyaffecting a muscle controlled by that nerve. For example, in the papertitled “Contactless Nerve Stimulation and Signal Detection by InductiveTransducer” presented at the 1969 Symposium on Application of Magnetismin Bioengineering, Maass et al. disclosed that a nerve threading thelumen of a toroid could be stimulated by a magnetic field of 0.7 Voltpeak amplitude and a 50 μs duration in a monitor wire, and that suchstimulation could generate a contraction of major leg muscles inanesthetized mammals.

Various attempts were made in the prior art to use PES for treating avariety of ailments. For example, U.S. Pat. No. 4,548,208 to Niemidiscloses an apparatus for inducing bone growth by generating anelectric current in the body through the external application of anelectromagnetic field. Such apparatus includes opposing clamps disposedon a limb and may optionally include feedback coils and a microprocessorfor sensing the magnetic field, so to avoid an overcurrent mode.Therefore, this apparatus optimizes the magnetic field on the basis ofmeasurements of the generated magnetic field.

U.S. Pat. No. 4,940,453 to Cadwell discloses a method and apparatus formagnetically stimulating the neural pathways of a higher level organism.In this invention, a sinusoidally fluctuating current flow is createdthrough a coil that overlies neurons to be stimulated, and frequency ofthe current flow and frequency of the magnetic field produced by thecoil predetermined to correspond to the time constant of the neurons tobe stimulated. Sensors for sensing coil conditions, such as coiltemperature, may also be included.

U.S. Pat. No. 5,000,178 to Griffith discloses an electrical toelectromagnetic transducer for applying electromagnetic energy todamaged parts of a living body by directing electromagnetic radiation toa certain damaged body part. Electromagnetic radiation is initiallygenerated by a dipole consisting of a bar of high permeability materialwrapped with an electrically conductive coil. Magnetic fields, which aregenerated away from the damaged body part, intersect a conductive shieldand establish eddy currents, which in turn generate magnetic fieldsopposite and nearly equal to the magnetic fields generated by theelectromagnetic source. The resultant electromagnetic fields reinforcethe electromagnetic field directed towards the damaged body part anddiminish the electromagnetic field directed away from the damaged bodypart.

U.S. Pat. No. 5,014,699 to Pollack et al. discloses a non-invasive,portable electromagnetic therapeutic method and apparatus for promotingthe healing of damaged or diseased living tissue, including fracturedbone. These method and apparatus involve generating a signal that has aseries of substantially symmetric voltage cycles of bursted pulses withnarrow pulse widths of 0.5 to 20 microseconds, and further involveconverting the signal into an electromagnetic field extending into anarea that contains tissue to be healed. This invention provides for nofeedback on the efficiency of the applied stimulation.

In a paper titled “Selective Stimulation and Blocking of Sacral Nerves:Research Setup and Preliminary Results,” published in AnnualInternational Conference of the IEEE Engineering in Medicine and BiologySociety, Vol. 13, No. 2, 1991, Wijkstrda et al. used an external pulsedmagnetic coil to stimulate a peripheral nerve for the treatment ofurinary incontinence. The authors used a large magnetic field producedby a single coil to ensure that the nerve was fired and the resultingnerve conduction was frequently painful or intolerable. In addition,coil alignment was problematic because an internally implanted coil wasutilized, which had to be aligned with the fully external magnetic fieldto stimulate the nerve. Due to the difficulty in positioning the device,the practical application of this therapy does not permit homehealthcare usage without a preset alignment and monitoring of the nerve,and no provision was made to insure that the nerve was actually beingstimulated or to adjust the device in response to commonly occurringphysiologic and anatomic variations in nerve locations.

U.S. Pat. Nos. 5,181,902 Erickson et al. and 5,314,401 to Tepperdisclose pulsed electromagnetic field (“PEMF”) transducer systems usableto perform PEMF therapies (such as after spinal fusion) by generatingflux-aided electromagnetic fields. The drive electronics includes a PEMFprocessor that executes a PEMF program for controlling the activation ofthe electromagnetic fields (field strength and cycle).

In a paper titled: “Magnetic Stimulation of the Bladder in Dogs”presented at the 1993 AAEM Annual Meeting, the abstract of which waspublished in the Muscle & Nerve issue of October 1993, Lin et al.disclosed that magnetic stimulation could be employed to stimulate thecortex, spinal nerves and peripheral nerves of dogs through directtrans-abdominal stimulation of the detrusor muscles or throughstimulation of the lumbosacral roots.

As shown, the prior art makes no provision to measure the efficacy ofPES treatment, causing patients to be treated improperly, either by aninsufficient or excessive exposure to PES. Other attempts to monitor PESdosage in the prior art exhibit serious drawbacks. For example, U.S.Pat. No. 5,518,495 to Kot discloses an apparatus for the treatment ofarthritis utilizing a magnetic field therapy, which includes anadjustable voltage source that is connected to a source of line voltageand a coil connected to the adjustable voltage source. This apparatushas no feedback system to advise a healthcare provider of the efficiencyof the treatment.

U.S. Pat. No. 5,984,854 to Ishikawa et al. discloses a method fortreating urinary incontinence based on delivering a train of currentpulses through one or more magnetic stimulation coils so to induce atrain of magnetic flux pulses, which then induce an eddy current withinthe body and stimulates a group of pelvic floor muscles, the pudendalnerve, the external urethral sphincter, or the tibial nerve. While thismethod includes the use of pulsed electromagnetic for treating urinaryincontinence, no specific components are envisioned to facilitate theplacement of the magnetic coils over a targeted region of the body or asystem for monitoring the efficiency of the therapy being applied.

U.S. Pat. No. 6,086,525 to Davey et al. discloses a magnetic nervestimulator that includes a core constructed from a material having ahigh field saturation having a coil winding disposed thereon. Athyrister capacitive discharge circuit pulses the device, and a rapidlychanging magnetic field is guided by the core, preferably made fromvanadium permendur.

U.S. Pat. No. 6,701,185 to Burnett et al. also discloses anelectromagnetic stimulation device that includes a plurality ofoverlapping coils, which can be independently energized in apredetermined sequence such that each coil will generate its ownindependent electromagnetic field and significantly increase theadjacent field. Unfortunately, none of these patents provides a systemfor monitoring the efficiency of the therapy in progress, either withrespect to the proper positioning of the winding over the area to betreated or of the intensity of the magnetic field to be applied.

Other PES therapies require the implantation of devices into thepatient, with the consequent discomfort, risk and cost to the patient.For example, U.S. Pat. No. 6,735,474 to Loeb et al. discloses a methodand system for treating UI and/or pelvic pain by injecting orlaparoscopically implanting one or more battery-or radiofrequency-powered microstimulators that include electrodes placedbeneath the skin of the perineum and/or adjacent the tibial nerve.

U.S. Pat. No. 6,941,171 to Mann et al. describes a method and a systemfor treating incontinence, urgency, frequency, and/or pelvic pain thatincludes implantation of electrodes on a lead or a discharge portion ofa catheter adjacent the perineal nerve(s) or tissue(s) to be stimulated.Stimulation pulses, either electrical or drug infusion pulses, aresupplied by a stimulator implanted remotely through the lead orcatheter, which is tunneled subcutaneously between the stimulator andstimulation site.

Other PES therapies in the prior art involve the use of electrodesplaced on or beneath the skin of a patient. Recent data on invasive,needle-based PES of the posterior tibial nerve in individuals with OABand UI indicates that PES can modulate bladder dysfunction through itsaction on the pudendal nerve and the sacral plexus, which provide themajor excitatory input to the bladder.

In a paper titled “Percutaneous Tibial Nerve Stimulation via Urgent® PCNeuromodulation System—An Emerging Technology for managing OveractiveBladder,” which was published in Business Briefing: Global Surgery 2004,CystoMedix, Inc. disclosed that peripheral tibial nerve stimulation(“PTNS”) had been found effective in treating OAB. The disclosedprocedure involved the use of electrode and generator components,including a small 34-gauge needle electrode, lead wires and a hand-heldelectrical generator. However, the procedure requires the permanentimplantation of an electrical stimulation device in the patient. Oneestimate put the cost of treatment at nearly $14,000 with additionalroutine care costs of $593 per patient per year. Additionally, risks ofbattery failure, implant infection, and electrode migration led to ahigh re-operation rate and made this procedure unattractive.

U.S. Pat. No. 7,117,034 to Kronberg discloses a method for generating anelectrical signal for use in biomedical applications that includes twotiming-interval generators. In this invention, skin-contact electrodesmay be placed over an area of interest and a microprocessor may directtiming and sequencing functions, although such timing and sequencingfunctions are not related to the actual efficacy of the treatment whiletreatment is being performed.

U.S. Patent Application Publication No. 2005/0171576 to Williams et al.discloses an electro-nerve stimulation apparatus that includes a pulsegenerator, a first electrically conductive, insulated lead wire, asecond electrically conductive, insulated lead wire, an electricallyconductive transcutaneous electrode and an electrically conductivepercutaneous needle electrode. Connected to one end of the first andsecond lead wires is a connector for electrically coupling with thepulse generator. In this invention, a percutaneous needle electrode isinserted through the skin in proximity to the desired internalstimulation site and electric stimulation is employed, rather thanpulsed electromagnetic stimulation. Moreover, the Williams inventiondoes not contemplate mechanisms for facilitating use of the device by anuntrained user, nor a monitoring of the applied therapy.

A neuromodulation alternative is a posterior tibial nerve stimulator,often referred to as SANS, but as is the case with other forms ofneuromodulation, this procedure is invasive in nature and requires theinsertion of a needle five centimeters into the patient's ankle regionto stimulate the posterior tibial nerve. This procedure also requires aminimum of twelve sessions for initial treatment, possibly withadditional sessions required for maintenance.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide apparatus andmethods for magnetic induction therapy, in which dosage of magneticenergy can be regulated according conduction in a target nerve exposedto the magnetic field.

It is another object of the present invention to provide apparatus andmethods for magnetic induction therapy, in which the flow of magneticenergy can be adjusted directionally by the patient or a healthcareprovider without altering the position of a housing containingconductive coils that produce the magnetic field.

It is a further object of the present invention to provide apparatus andmethods for treating a variety of ailments by providing energy to atarget nerve, for example magnetic energy, electrical energy orultrasound energy, at a location and in an amount optimized by detectingconduction in the target nerve.

These and other objects of the present invention are achieved byproviding an energy emitting apparatus for delivering a medical therapythat includes one or more energy generators, a logic controllerelectrically connected to the one or more energy generators, and one ormore sensors for detecting electric conduction in a target nerve, whichare connected to the logic controller. The one or more energy generatorsproduce energy focused on the target nerve upon receiving a signal fromthe logic controller, and the applied energy is varied by the logiccontroller according to an input provided by the one or more sensorsbased on electric conduction in the target nerve. The feedback providedby the sensors to the logic controller about the efficacy of the appliedtreatment causes the logic controller to modulate the currenttransmitted to the coils.

The applied energy may be a magnetic field, an electrical field, anultrasound, a visible light, or an infrared or an ultraviolet energy.When a magnetic field is applied, the energy-emitting device is anapparatus that provides a magnetic induction therapy and that includesone or more conductive coils disposed in an ergonomic housing. A logiccontroller is electrically connected to the one or more coils, and oneor more sensors detect electric conduction in the target nerve and areconnected to the logic controller so to provide a feedback to the logiccontroller. The conductive coils receive an electric current from thelogic controller and produce a magnetic field focused on a target nerve,and the electric current fed by the logic controller is varied by thelogic controller according to an input provided by the sensors, therebycausing amplitude, frequency or direction of the magnetic field, or thefiring sequence of the one or more coils, to be varied according to theefficiency of the treatment provided to the target nerve. In differentembodiments of the invention, the housing containing the conductivecoils may be a flexible wrap, a cradle or a garment, and the coils maybe overlapping and/or be disposed in different positions within thehousing, so to generate a magnetic field on different body parts withthe desired direction and amplitude.

The one or more coils may be stationary or movable within the housing,making it possible to optimize the direction of magnetic flow to thetarget nerve by disposing the coils in the most effective direction. Indifferent embodiments, the coils may be movable manually by acting on aknob, lever, or similar type of actuator, or may be translatedautomatically by the logic controller in response to the input providedby the sensors. When a preferred position for the coils has beenestablished, the coils may be locked in position and maintain thatposition during successive therapy sessions. In other embodiments, thesensors may be incorporated within the housing, or instead may bedisposed on a body part of interest independently of the housing.

In still other embodiments of the invention, the inductive coils aredisposed in a housing that is situated externally to a patient's body,and additional inductive coils are implanted into the body of thepatient and are magnetically coupled to the external inductive coils.With this coil arrangement, energy may be transmitted from the externalcoils to the internal coils either to recharge or to activate animplantable device. In yet other embodiments of the invention, theelectric current may varied by the logic controller both on the basis ofan input provided by the one or more sensors and also an input providedby the patient according to a muscular response she has perceived, forexample, the twitching of a toe after application of the magnetic field.

In yet other embodiments of the invention, the source of energy fornerve stimulation may be electrical energy and nerve conduction may bedetected at a site sufficiently distant from the site of stimulation, soto enable detection of nerve conduction despite the confoundinginterference from the direct electrical stimuli. In these embodiments,direct electrical stimulation of nerve and muscle may be tailored toprovide optimal therapy and, in the case of electrode migration or otherelectrode malfunction, to report lack of stimulation of the bodilytissues. Furthermore, these embodiments enable a reduction in powerrequirement, because control of the signal is provided by the sensor tothe signal generator loop.

Methods of use of the above apparatus are also described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings constitute a part of this specification and includeexemplary embodiments of the invention, which may be embodied in variousforms. It is to be understood that in some instances various aspects ofthe invention may be shown exaggerated or enlarged to facilitate anunderstanding of the invention.

FIG. 1 is a schematic view of an apparatus for magnetic inductiontherapy according to a first embodiment of the invention.

FIG. 2 is a schematic view of an apparatus for magnetic inductiontherapy according to a second embodiment of the invention.

FIG. 3 is a schematic view of an apparatus for magnetic inductiontherapy according to a third embodiment of the invention.

FIG. 4 is a schematic view of an apparatus for magnetic inductiontherapy according to a fourth embodiment of the invention.

FIG. 5 is a schematic view of an apparatus for magnetic inductiontherapy according to a fifth embodiment of the invention.

FIGS. 6A-6D are schematic illustrations depicting a first method of useof an apparatus for magnetic induction therapy. This method is based onadjusting the position of the conductive coils so to optimize a magneticflow applied to a target nerve.

FIGS. 7A-7D are schematic illustrations of a second method of use of anapparatus for magnetic induction therapy. This method is based onlocking the conductive coils in position once electrical conduction in atarget nerve has been detected.

FIG. 8 is a schematic view of an embodiment of the invention thatincludes a plurality of sensors.

FIGS. 9A-9D are schematic representations of different garments adaptedto operate as apparatus for magnetic induction therapy according to theprinciples of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

Detailed descriptions of embodiments of the invention are providedherein. It is to be understood, however, that the present invention maybe embodied in various forms. Therefore, the specific details disclosedherein are not to be interpreted as limiting, but rather as arepresentative basis for teaching one skilled in the art how to employthe present invention in virtually any detailed system, structure, ormanner.

Referring first to FIG. 1, a first embodiment of the invention includesa coil wrap 20, which is depicted as disposed over ankle 22circumferentially to surround a portion of tibial nerve 24. Becausetibial nerve 24 is targeted, this embodiment is particularly suited forthe treatment of OAB and VI. In other embodiments of the invention, coilwrap 20 may be configured to surround other body parts that contain aportion of tibial nerve 24 or of other nerves branching from orconnected to tibial nerve 24, still making these embodiments suitablefor treating OAB and VI. In still other embodiments of the invention,coil wrap 20 may be configured for surrounding body parts that containother nerves when treatments of other ailments are intended.

Coil wrap 20 may be manufactured from a variety of materials suitablefor wearing over ankle 22. Preferably, coil wrap is produced from asoft, body-compatible material, natural or synthetic, for example,cotton, wool, polyester, rayon, Gore-Tex®, or other fibers or materialsknown to a person skilled in the art as non-irritating and preferablybreathable when tailored into a garment. Coil wrap 22 may even bemanufactured from a molded or cast synthetic material, such as aurethane gel, to add extra comfort to the patient by providing a softand drapable feel. Additionally, coil wrap 20 may be produced from asingle layer of material or from multiple material layers and mayinclude padding or other filling between the layers.

Coil wrap 20 contains one or more conductive coils 26 arranged toproduce a pulsed magnetic field that will flow across tibial nerve 24and generate a current that will flow along tibial nerve 24 and spreadalong the length of tibial nerve 24 all the way to its sacral orpudendal nerve root origins. Coils 26 may be a single coil shaped in asimple helical pattern or as a figure eight coil, a four leaf clovercoil, a Helmholtz coil, a modified Helmholtz coil, or may be shaped as acombination of the aforementioned coils patterns. Additionally, othercoil designs beyond those mentioned hereinabove might be utilized aslong as a magnetic field is developed that will encompass tibial nerve24 or any other target nerve. When a plurality of coils is utilized,such coils may be disposed on a single side of ankle 22, or may bedisposed on more than one side, for example, on opposing sides,strengthening and directionalizing the flow of the magnetic fieldthrough tibial nerve 24 or other peripheral nerves of interest.

Coil wrap 20 is preferably configured as an ergonomic wrap, for example,as an essentially cylindrical band that can be pulled over ankle 22, oras an open band that can be wrapped around ankle 22 and have its endsconnected with a buckle, a hoop and loop system, or any other closingsystem known to a person skilled in the art. By properly adjusting theposition of coil wrap 20 over ankle 22, a patient or a health careprovider may optimize the flow of the magnetic field through tibialnerve 24, based on system feedback or on sensory perceptions of thepatient, as described in greater detail below.

The electric current that produces the magnetic field by flowing throughcoils 26 is supplied by a programmable logic controller 28, which isconnected to coils 26, for example, with a power cord 32. A sensor 30that feeds information to logic controller 28 is also provided, in orderto tailor the strength of the magnetic field and control activation ofcoils 26 based on nerve conduction. The purpose of sensor 30 is todetect and record the firing of the target nerve and to provide relatedinformation to logic controller 28, so to render the intended therapymost effective. For example, sensor input may cause logic controller 28to alter the strength or pulse amplitude of the magnetic field based onsensor input, or fire the coils in a certain sequence.

In this embodiment, as well as in the other embodiments describedhereinafter, sensor 30 may include one or more sensor patches and may beplaced at different distances from the region of direct exposure to themagnetic field. For example, sensor 30 may be configured as a voltage orcurrent detector in the form of an EKG patch and may be placed anywherein the vicinity of the target nerve to detect its activation. For easeof description, the term “coils” will be used hereinafter to indicate“one or more coils” and “sensor” to indicate “one or more sensors,”unless specified otherwise.

By virtue of the above described arrangement, coil wrap 20 provides areproducibly correct level of stimulation during an initial therapysession and during successive therapy sessions, because the presence orabsence of nerve conduction is detected and, in some embodiments,measured when coil wrap 20 is first fitted and fine-tuned on thepatient. In addition to properly modulating the applied magnetic field,the positioning of coils 26 over ankle 22 may also be tailored accordingto the input provided by sensor 30, so to fine-tune the direction of themagnetic field. Such an adjustment of the direction, amplitude, andlevel of the stimulation provided to the target nerve through the abovedescribed automated feedback loop, to ensure that peripheral nerveconduction is being achieved, is one of the key features in the presentinvention.

If the magnetic pulse does not substantially interfere with sensor 30,sensor 30 may be placed directly within the field of stimulation, sothat power supplied to the system may be conserved. This is particularlyimportant for battery-powered systems. Alternatively, sensor 30 may alsobe placed at a distance from the magnetic field and still properlydetect neural stimulation.

In a method of use of coil wrap 20, the amplitude and/or firing sequenceof coils 26 may be ramped up progressively, so that the magnetic fieldis increased in strength and/or breadth until nerve conduction isdetected, after which the applied stimulus is adjusted or maintained atits current level for the remainder of the therapy. The level ofstimulation may be also controlled through a combination of feedbackfrom sensor 30 and feedback based on perceptions of the patient. Forexample, the patient may activate a switch once she perceives anexcessive stimulation, in particular, an excessive level of muscularstimulation. In one instance, the patient may be asked to push a buttonor turn a knob when she feels her toe twitching or when she experiencesparesthesia over the sole of her foot. The patient will then continuepressing the button or keep the knob in the rotated position until shecan no longer feel her toe twitching or paresthesia in her foot,indicating that that level of applied stimulation corresponds to anoptimal therapy level. From that point on, the patient may be instructedto simply retain her foot, knee, or other limb within coil wrap 20 untiltherapy has been terminated while the system is kept at the optimallevel. Adding patient input enables control of coil wrap 20 duringoutpatient treatments, because the patient is now able to adjust theintensity of the magnetic field herself beyond the signals provided tologic controller 28 by sensor 30.

Detecting and, if the case, measuring conduction in one or more nervesalong the conduction pathways of the stimulated nerve confirms that thetarget nerve has been stimulated, providing an accurate assessment ofthe efficiency of the applied therapy on the patient. A concomitantdetection of muscle contraction may also confirm that the target nerveis being stimulated and provide an indication to the patient or to ahealthcare provider as to whether stimulation has been applied at anexcessive level in view of the anatomical and physiologicalcharacteristics of the patient.

Based on the foregoing, coil wrap 20 allows for a consistent,user-friendly targeting and modulation of the peripheral nerves via theposterior tibial nerve on an outpatient basis, in particular, thetargeting and modulation of the pudendal nerve and of the sacral plexus.When multiple coils 26 are present, coils 26 may be activatedsimultaneously or differentially to generate the desired magnetic field.The direction and location of each of coils 26 may be reversibly orirreversibly adjusted by the healthcare provider or by the patient,customizing the location of the applied stimulation to the anatomy andtherapy needs of each patient. After a healthcare provider has optimizedposition and firing sequence for each of coils 26, the patient may besent home with coil wrap 20 adjusted to consistently target the desirednerve. In one variant of the present embodiment, an automatic feedbacksystem adjusts one or more of firing sequence, firing strength orposition of coils 26 within coil wrap 20 during the initial setup andalso during successive therapy sessions.

In summary, the teachings of the present invention include the creationof a loop consisting of feeding information on nerve conduction to logiccontroller 28 and on logic controller 28 tailoring the electricalcurrent sent to coil wrap 20 according to the information received fromsensor 26 based on whether or not the nerve is receiving the desiredstimulation and, in some embodiments, the desired amount of stimulation.This arrangement offers an unparalleled level of therapy control andflexibility within a home care setting, because a consistent, repeatablestimulation of the target nerve can be attained. Aside from adjustingthe position of coils 26 in accordance with the patient's anatomy andphysiological variations, controlling pulse amplitude is also of greatimportance even during different therapy sessions with the same patient.For example, a patient with leg edema will encounter difficulties inproperly adjusting coil wrap 20 based on whether her legs and ankles areswollen or not swollen, and the power required to penetrate to posteriortibial nerve 24 (in the case of a VI therapy) will vary greatly due tothe variable depth of the nerve. Thus, having feedback provided bysensor 26 becomes a necessity for achieving an accurate dosage of thetreatment rather than an option. Benchtop testing has demonstrated thata system constructed according to the present invention is capable ofnon-invasively generating electrical currents similar to those found intherapeutic electro-stimulation and to do so in different settings.

Referring now to FIG. 2, a second embodiment of the invention will bedescribed with reference to a coil wrap 34 disposed over ankle 36 forthe purpose of treating VI by targeting tibial nerve 38. In this secondembodiment, one or more Helmholtz coils 40 are disposed within coil wrap34 to create a more narrowly directed magnetic field over tibial nerve38. Like in the all other embodiments described herein, more than onecoil (in the present embodiment, more than one Helmholtz coil 40) may beplaced within coil wrap 34 and be disposed in different positions withincoil wrap 34, in order to optimize magnetic flux over tibial nerve. Forexample, two Helmholtz coils may be disposed one opposite to the otherwithin coil wrap 34.

Having coil windings arranged along a common longitudinal axis, asrequired in a Helmholtz coil configuration, generates a more focusedmagnetic field and a more accurate targeting of tibial nerve 38 or ofany other nerve. Like in the previous embodiment, the operation of coils40 is controlled by a logic controller 42, which is in turn connected tosensor 44 that monitors conduction in tibial nerve 44 and that generatesa feedback to logic controller 42 about the efficiency of the therapy inprogress. Therefore, like in the previous embodiment, the coupling ofsensor 44 with logic controller 42 optimizes operation of coil wrap 34according to results measured at the level of tibial nerve 38. Also likein the previous embodiment, manual adjustments to the parameters ofelectric current provided by logic controller 42 to Helmholtz coil 40may also be made manually by the patient or by a healthcare provider,and coil wrap 34 may be structured so that the position of Helmholtzcoil 40 within coil wrap 34 is adjusted as desired either manually bythe patient or by a healthcare provider, or automatically by logiccontroller 42.

Referring now to FIG. 3, a third embodiment of the invention includes acoil wrap 46 configured for wrapping over the popliteal fossa of apatient, in the region of the knee, to stimulate the posterior tibialnerve (not shown). The configuration and structure of coil wrap 46reflect the body portion covered by coil wrap 46, but the key systemcomponents of coil wrap 46, such as the type, number and disposition ofthe coils (for example, the use of overlapping coils); the connectionsof the coils with a logic controller; and the use of one or more sensors(also not shown) to detect nerve conduction are all comparable to thosein the previously described embodiments.

Referring now to FIG. 4, a fourth embodiment of the invention includes afootrest or foot cradle 48, which is structured to contain at least aportion of a foot 50. One or more coils 52 are enclosed within cradle48, and a sensor 54 is disposed along the pathway of tibial nerve 55,sensing conduction in tibial nerve 55, and is also connected to a logiccontroller 56. Coils 52, sensor 54 and logic controller 56 may bearranged in different configurations, in the same manner as in thepreceding embodiments.

Cradle 48 may be made from a variety of materials and may be monolithic,or have a hollow or semi-hollow structure to enable the movement ofcoils 52 within cradle 48, as described in greater detail below.Preferably, cradle 48 has an ergonomically design allowing the ankle andheel of the patient to be retained within cradle 48, in a position thatmatches the positions of stimulating coils 52 to the area ofstimulation. The design of cradle 48 provides for a particularlycomfortable delivery of therapy to patients that prefer to remain seatedduring their therapy, and enables the patient to perform the requiredtherapy within a health care facility, or to take cradle 48 home,typically after an initial session and appropriate training in a healthcare facility. In that event, the patient will be trained to applysensor 54 autonomously and to adjust stimulation to a comfortable level.

FIG. 4 shows coils 52 disposed as overlapping and the use of a singlesensor patch 54 positioned proximally to the stimulation site. However,coil 52 may be configured as a single coil, a figure eight coil, a fourleaf clover coil, a Helmholtz coil, a modified Helmholtz coil or a anycombination of the aforementioned coils, or as any other coil designproviding an effective stimulation to the target nerve. In addition,coils 52 may be fired individually, sequentially or simultaneouslyaccording to the feedback provided by sensor 54.

In one variant of this embodiment, sensor 54 may include a conductiveelectrode patch that provides a feedback to logic controller 56 foradjusting, if necessary, the stimulation parameters of coils 52.Alternatively, sensor 54 may be a sensor patch that is either applied tothe skin of the patient or is incorporated within the structure ofcradle 48.

Referring now to FIG. 5, a fifth embodiment of the invention includes aknee rest or knee cradle 58 that contains one or more conductive coils60, one or more sensors 62 and a logic controller 64. The components ofthis embodiment are similar to those described with reference to thepreceding embodiments, as regards the structure and materials of cradle58, the nature and disposition of coils 60, the type and operation ofsensor 62, and the function and operation of logic controller 64. Cradle58 is configured to target the popliteal fossa of the patient, thus totarget tibial nerve 66. In that respect, the present embodiment issimilar to the embodiment illustrated in FIG. 3, but while theembodiment of FIG. 3 is configured as a wrap that may be worn while thepatient is standing, the present embodiment is configured as a cradlethat is more suited for treatment while the patient is sitting or layingdown.

A method of use of the foot cradle depicted in FIG. 4 is described withreference to FIGS. 6A-6D. During a first step illustrated in FIG. 6A,foot 68 is disposed in cradle 70 that contains one or more conductivecoils 72, which are connected to a logic controller (not shown) thatmanages the flow of electric power to coils 72.

During a second step illustrated in FIG. 6B, a sensor 74 is disposed onfoot 68 or on ankle 76 or on another appropriate portion of thepatient's body, in order to detect conductivity in tibial nerve 78 or inanother target nerve.

During a third step illustrated in FIG. 6C, a healthcare provideranalyzes conductivity measurements provided by sensor 74 (for example,by reading gauge 77) and first adjusts the positioning of coils 72 untilconduction in nerve 78 is detected. For example, the healthcare providermay rotate a knob 80, slide a lever or actuate any other displacementsystem for coils 72 that is known in the art, so that coils 72 aretranslated until a magnetic field of the proper amplitude and intensityis applied to cause conduction in nerve 78. The position of coils 72 isthen fine-tuned manually until an optimal level of conduction in nerve78 is attained, and the therapy is continued for a length of time asprescribed by the attending healthcare provider.

During a fourth, optional step illustrated in FIG. 6D, settings forsuccessive therapy sessions are set, for example by locking knob 80 (inone embodiment, with a pin 81) so that the healthcare provider or thepatient repeat the therapy using the predetermined settings.Alternatively, the patient may be trained to adjust the amplitude and/orstrength of the applied magnetic field, as each therapy sessionrequires.

While the present method has been described with regard to foot cradle70, the same method steps may be envisioned for coil wraps or cradles ofdifferent configurations, for example, for the coil wraps and cradlesdescribed with reference to the previous figures.

In an alternative embodiment, the logic controller (not shown) mayautomatically adjust coil positioning to optimize therapy during theinitial and successive sessions. While this set-up may be more difficultto implement, it also provides for an accurate targeting of the targetnerve during each therapy session, regardless of alterations in patientpositioning or changes to the anatomy of the patient (for example, whena foot is swollen). In this embodiment, the device simply varies theorientation of coils 84 until stimulation has been sensed.

Further, coils 84 may be translated along a single direction (forexample, horizontally) or along a plurality of directions, to providefor the most accurate positioning of coils 84 with respect to the targetnerve.

A second method of use of the foot cradle depicted in FIG. 4 isdescribed now with reference to FIG. 7. While this second method is alsodescribed with reference to a foot cradle 82 employing one or more coils84 that have a reversibly lockable, adjustable orientation, the presentmethod may be equally implemented with a body-worn coil wrap, such asthose described with reference to the previous figures, or to otherembodiments of the invention. In this method, the patient or thehealthcare provider adjusts the positioning of coils 84 to detectconductivity in target nerve 89.

The position of coils 84 may be translated in different directions (inthe illustrated embodiment, may be translated horizontally) and may belocked in an initial position once conduction in nerve 89 is detected bya sensor (for example, sensing patch 86)

More particularly, FIG. 7A illustrates the initial positioning of foot88 into cradle 82 and of sensor patch 86 on ankle 90 or otherappropriate body part of the patient. After proper positioning of foot88 is attained, a knob 92 (or other equivalent device) may be employedto adjust the position of coils 84, based on the signals (for example,nerve conduction signals) provided by sensor patch 86, as shown in FIG.7B.

With reference to FIG. 7C, after neural conduction is detected, coils 84are locked in place, and, with further reference to FIG. 7D, foot cradle82 retains coils 84 locked in position for further use in a home orhealthcare office environment. Therefore, in the present method, thepatient or a healthcare provider simply adjusts coil position by slidingcoils 84 back and along one axis until electric conduction in the targetnerve is detected, although adjustments along all three axes may bepossible in different variants of the present embodiment.

Referring now to FIG. 8, a sixth embodiment of the invention relates tothe use of multiple sensors. While FIG. 8 depicts an embodiment shapedas a foot cradle 98, it should be understood that the followingdescription also relates to any other design, whether shaped as a cradleor a wrap or otherwise. The plurality of sensors 94 described herein maydetect a variety of physiologic changes, including neural impulses,muscular contraction, twitching, etc. that may occur with neural ormuscular stimulation.

One or more of the illustrated sensors 94 may be employed over bodyregions being stimulated (for example, back, leg, arm, neck, head,torso, etc.) and may be either incorporated within an actual cradle orwrap or, otherwise, be applied separately from the cradle or the wrap.

Sensors 94 may be structured as disposable, single-use, EKG-type patchesthat are attached to the body outside of cradle 98 along the nerveconduction pathway and are then connected to the logic controller (notshown) before beginning therapy. This arrangement provides for anintimate body contact of sensors 94 without the risk of infection orother detrimental side effects that may be present with transcutaneousdevices. Sensors 94 may be employed both for beginning and formonitoring the stimulation therapy; more specifically, sensors 94 may beemployed during the beginning of the therapy to optimize the strength ofthe magnetic field and/or to adjust the positioning of coils 96 withinthe cradle 98. Once therapy has begun, sensors 94 continue to monitornerve conduction to ensure that the correct level of stimulation isbeing provided. In the event that for some reason nerve conductiondecays during therapy, the logic controller can automatically adjust themagnetic field, ensuring that the appropriate therapy is delivered forthe appropriate amount of time.

One or more of sensors 94 in this embodiment, or any of the embodimentsdescribed herein, may take the form of an inductive coil designed toreceive impulses from the underlying nerves, so that inductivetechnologies may be used to both stimulate the nerve or tissues as wellas to record the effect of the stimulation on nerves or tissues. Any ofsensors 94 may be connected to the logic controller through one or moreconnection modes, including, but not limited to, wireless signals, wiredsignals, radio frequencies, Bluetooth, infrared, ultrasound, directswitching of the current circuit, etc., so long as communication betweenthe sensor and the device is effective.

During implementation of the present method, a healthcare provider maysimply elect to use sensors 94 to adjust the device, for example, tolock coils 96 into position, during the first therapy session and notrequire the use of sensors 94 during each successive therapy session.

Referring now to FIGS. 9A-9D, there are shown different, non-limitingembodiments of the invention shaped as body worn ergonomic applicatorgarments. Each of these embodiments is shown with overlapping coils,although coils of any configurations may be used. Each of the wraps ofFIGS. 9A-9D corresponds to a coil wrap, into which a body part may beplaced. These garments contain one or more sensors (not shown) thatprovide feedback to a logic controller (also not shown), or sensors maybe applied separately from those garments. Systems may also be includedfor reversibly or irreversibly locking the coils within the applicator.

More particularly, FIG. 9A illustrates an embodiment, in which coils 100are embedded in a knee wrap 102 and are connected to a logic controller(not shown) by a connector 104. FIG. 9B instead illustrates anembodiment, in which coils 106 are disposed within an abdominal garment,for example shorts 108 and in which coils 106 are also connected to alogic controller (not shown) by a connector 110. A marking 112 may beadded on one side of shorts 108 to indicate wrap orientation. FIG. 9Cillustrates a coil wrap shaped like a band 114, in which coils 116 areconnected to a logic controller (not shown) by a connector 118. Whenthis embodiment is employed, band 114 may be wrapped around a bodyportion (for example, an arm) and be retained in place by a system knownin the art, for example, a hook and loop system, a strap and bucklesystem, or simply a hook disposed at one end of band 114 for engagingfabric or other material in another portion of band 114. FIG. 9Dillustrates an embodiment shaped as a shoulder strap 120, the length ofwhich may be adjusted by a buckle 122 and which has coils 124 disposedin one or more points, for example, at the joint between an arm and ashoulder as shown. Each of these embodiments includes one or moresensors (not shown) that may coupled to the garment, or that may appliedseparately from the garment.

Other embodiments that are not illustrated include, bur are not limitedto: a head worn garment, such as a cap; a neck worn garment, such as aneck brace; and a lower-back garment. Each garment and applicator mayalso utilize the locking, targeting coil feature described previously,without requiring the use of the any sensing components after a properpositioning of the coils in relation to the target nerve or nerves hasbeen established.

Still other embodiments of the invention are depicted in FIGS. 10 and11. In these embodiments, the source of energy for nerve stimulation iselectrical energy that is dispensed through a percutaneous stimulator,such as a percutaneous needle 124, or a transcutaneous stimulator, suchas an electrode 126. As shown in FIG. 10, an electrical pulse controller128 is electrically connected both to percutaneous needle 124 and tosensor 134, to provide the desired feedback and modulate the power topercutaneous needle 134. In the embodiment of FIG. 11, electrical pulsecontroller 130 is connected both to electrode 126 and to sensor 136, andperforms a function similar to that of electrical pulse controller 128.With these embodiments, nerve conduction may be detected at a sitesufficiently distant from the site of stimulation, so to enabledetection of nerve conduction despite the confounding interference fromthe direct electrical stimuli. Further, direct electrical stimulation ofnerve and muscle may be tailored to provide optimal therapy and, in thecase of electrode migration or other electrode malfunction, to reportlack of stimulation of the bodily tissues. Still further, theseembodiments enable a reduction in power requirement, because control ofthe signal is provided by the sensor to the signal generator loop.

As shown, a device constructed according to the principles of thepresent invention provides a targeted and precise stimulation of theposterior tibial nerve, or of other peripheral nerves, in a non-invasivemanner by employing an ergonomic wrap or cradle that specificallytargets the posterior tibial nerve in a consistent and repeatablemanner. For example, in patients with OAB or VI, the novel, reversiblylockable movement of the coils and the use of a logic controller—sensorloop enables the application of a magnetic field that can be varied inlocation, amplitude and strength according to the amount of stimulationactually induced in one or more target nerves and of the response of thepatient to the therapy. An apparatus according to the present inventionmay deliver any frequency of stimulation, including low frequencies,high frequencies, mid frequencies and ultrahigh frequencies, andoverlapping and non-overlapping coils may be used to generate thedesired field, although overlapping or Helmholtz coils are preferred dueto their ability to target a broader region and achieve more thoroughstimulation.

Ailments that may be treated through the use of apparatus and methods ofthe present invention include not only OAB and VI, but also obesity,depression, urinary incontinence, fecal incontinence, hypertension,pain, back pain, restless leg syndrome, Guillain Barre syndrome,quadriplegia, paraplegia, diabetic polyneuropthy, dyskinesias,paresthesias, dental procedure pain, knee osteoarthritis, anesthesia(pain relief during surgery), Alzheimer's disease, angina (chest painfrom heart disease), ankylosing spondylitis, back pain, burn pain,cancer pain, chronic pain, dysmenorrhea (painful menstruation),headache, hemiplegia, hemiparesis (paralysis on one side of the body),labor pain, local anesthesia during gallstone lithotripsy, facial pain,trigeminal neuralgia, bruxism (tooth grinding) pain, myofascial pain,pregnancy-related nausea or vomiting, neck and shoulder pain, pain frombroken bones, rib fracture or acute trauma, diabetic peripheralneuropathy, phantom limb pain, post-herpetic neuralgia (pain aftershingles), postoperative ileus (bowel obstruction), irritable bowelsyndrome, postoperative nausea or vomiting, postoperative pain,post-stroke rehabilitation, rheumatoid arthritis, skin ulcers, spinalcord injury, temporomandibular joint pain, detrusor instability, spinalmuscular atrophy (in children), pain during hysteroscopy, gastroparesis,chronic obstructive pulmonary disease rehabilitation, carpal tunnelsyndrome, soft tissue injury, multiple sclerosis, intermittentclaudication, attention-deficit hyperactivity disorder (ADHD), cognitiveimpairment, knee replacement pain, achalasia, atopic eczema, bursitis,carpal tunnel syndrome, dementia, depression, dry mouth, dystonia,enhanced blood flow in the brain, enhanced blood perfusion of the uterusand placenta, esophageal spasm, fibromyalgia, fracture pain,Guillain-Barre syndrome, hemophilia, herpes, hip pain, interstitialcystitis, irritable bowel syndrome, pruritis, joint pain, laborinduction, local anesthesia, menstrual cramps, muscle cramps, musclespasticity, muscle strain or pain, musculoskeletal trauma, myofascialpain dysfunction syndrome, nerve damage, osteoarthritis, pain medicationadjunct, pancreatitis, Raynaud's phenomenon, repetitive strain injuries,sacral pain, schizophrenia, shingles, shoulder subluxation, sickle cellanemia pain, Skin flap ischemia (during plastic surgery), sphincter ofOddi disorders, sports injuries, thrombophlebitis, tinnitus (ringing inthe ear), restless legs, tremor, whiplash and neuralgias. In contrast toimplantable nerve stimulators, this therapy is completely non-invasiveand does not require a major surgery to implant a permanent nervestimulation device. Moreover, this therapy can be controlled to optimizethe level of therapy delivered according to power consumption and nervestimulation requirements and need not be delivered by a professionalhealthcare provider.

In other embodiments of the invention, neural stimulation may be appliedas electrical transcutaneous stimulation, for example, by inserting aninvasive electrical needle into a target body part and by modulatingstimulation is modulated on the basis of information sent back to thelogic controller from the one or more sensors that are used to detectand/or maintain the correct level of stimulation. The transcutaneouselectrical stimulation sensor may be placed in the body independently orbe incorporated within the wrap and may provide, among other things,feedback as to the quality of the electrical connection to the skin,which is directly related to the burn risk inherently associated withthis type of therapy. In fact, these methods of stimulation may not beoptimal due to the resulting skin irritation and risk of potentialburns, a very serious issue in the large percentage of patients thathave neuropathies. Even when patches are applied to monitortranscutaneous stimulation very closely, the patches may still becomedisplaced and allow a burn to occur. Moreover, potentially interferingelectrical impulses may develop at the treatment site, creating a noisyenvironment for the detection of nerve conduction.

In still other embodiments of the invention, an external coil or coilsmay be inductively connected to an implanted coil or coils may beutilized. In these embodiments, an ergonomic applicator may be adjustedby the user or by a healthcare provider such to optimize inductive powertransmission between the external and implanted coils. One or moresensors may be utilized to provide a feedback that the relative coilpositions have been optimized, and the external coil may then bereversibly locked into position within the ergonomic applicator. Twoapplications of this embodiment relate to the transfer of power torecharge an implantable device, and to the transfer of power to activatean implantable device.

In the first application, when an implantable rechargeable device isutilized, the external coils may be used for recharging the implanteddevice by means of inductive fields generated by the external coils. Theexternal coils may include circuitry that determines the amount ofresistance encountered by the magnetic field or other electricalproperties related to the quality and degree of the magnetic couplingthat is being established. Based on this feedback, the position of theexternal coils may be adjusted manually or automatically to optimize thecoupling achieved with during each recharging session. Alternatively, asensor may be incorporated into the implantable device and maycommunicate the degree and quality of the magnetic coupling to theexternal coils and/or the connected circuitry via wirelesscommunication, providing a feedback for the automatic or manualadjustment of the external recharging coils.

The coils within the ergonomic applicator may be reversibly locked intoplace for the duration of the recharge session, and the implantabledevice may also communicate to the external recharging unit that theimplantable device has been fully recharged, terminating the rechargingsession has been completed. By providing for an intermittent rechargingof an implanted device, an apparatus according to the present inventionenables the implantable device to devote more power to performing itsintended function optimally and with a lesser concern about protectingor extending battery life.

In the second application, the powering coils may contain circuitry todetermine the amount of resistance encountered by the applied magneticfield, or other electrical properties that may reflect the quality anddegree of the magnetic coupling that is being achieved. Based on thisfeedback, the powering coils in the applicator may be adjusted manuallyor automatically to activate and optimize the coil coupling at thebeginning of each therapy session. Alternatively, a sensor may beincorporated into the implantable device and communicate the degree andquality of the magnetic coupling externally via wireless communication,which may in turn provide feedback for the automatic or manualadjustment of the powering coil. In one variant of the presentembodiment, the inductive coils may be magnetically coupled to a needletargeting the posterior tibial nerve.

An exemplary method of use of an apparatus according to the presentinvention on a patient suffering from VI and/or OAB includes thefollowing steps:

The patient places a conductive wrap contained within a flexiblematerial over a region of the ankle (or alternatively over the knee) toprovide the required pulsed magnetic field. Alternatively, the patientmay use an ergonomic foot/leg rest or cradle having embedded coils.

A sensor (for example, a sensor patch) is placed on the patient's bodyalong the path of the nerve, ideally proximal to the stimulation site toensure afferent nerve stimulation, and is connected to a logiccontroller.

A physician or healthcare provider adjusts the coils in the wrap orcradle until nerve conduction is achieved based on patient and sensorfeedback. An optimal position is sought, and the coils may be reversiblylocked into position within the conductive wrap or ergonomic cradle andremain in this position during subsequent use.

During the therapy session, the logic controller provides an electriccurrent to the coils, generating an inductive magnetic field. In oneembodiment, this field begins at low amplitude and slowly ramps up untilnerve conduction exceeds a threshold level, as signaled by the sensorand possibly by the patient, who may feel motory conduction.Alternatively, one or more coils may also be activated to increase thecovered area of stimulation in the event that stimulation does not occurwith the initial coil configuration or is inadequate

The optimal stimulation may be determined in a variety of manners, forexample, by measuring exposure to electromagnetic fields capable ofgenerating a square wave electric signal at a frequency of 10-30 Hz atthe targeted tissue depth. The square wave configuration of the signalmay be generated via Fourier transformation or may be a ramped currentgenerated in any manner.

The inductive magnetic pulses continue for an appropriate duration ofuse, for example, for 15-30 minutes. The sensor may remain in placeduring the entire therapy session to ensure that stimulation occursconsistently and to provide for appropriate corrections if nerveconduction deteriorated. The logic controller may be powered either by aportable power source such as a battery, or by or a fixed power sourcesuch as a traditional wall outlet.

The conductive wrap and/or ergonomic cradle is removed from the bodywhen therapeutic stimulation is not being delivered, typically at theend of the therapy session.

The conductive wrap and/or ergonomic cradle is reapplied along with thesensor patch (ideally disposable) from time to time as indicated, forexample, on a daily basis, and steps 4-8 are repeated.

The invention described herein may be applied to any body tissues,including nerve, muscle, skin, vasculature, or any other organ or tissuewithin the human body. Further, the devices and methods described hereinmay be used to treat any conditions suited for neuromodulationregardless of whether the stimulation source is an electromagneticfield, a direct electric current, a RF field, infrared energy, visiblelight, ultraviolet light, ultrasound, or other energy dispensing device.

While the invention has been described in connection with the abovedescribed embodiments, it is not intended to limit the scope of theinvention to the particular forms set forth, but on the contrary, it isintended to cover such alternatives, modifications, and equivalents asmay be included within the scope of the invention. Further, the scope ofthe present invention fully encompasses other embodiments that maybecome obvious to those skilled in the art and the scope of the presentinvention is limited only by the appended claims.

1. A system for magnetic induction therapy comprising: at least oneconductive coil disposed within or along a housing, where the at leastone coil is configured to generate a magnetic field focused on a targetnerve in proximity to the at least one coil; at least one sensorconfigured to detect electrical conduction in the target nerve; and acontroller in communication with the at least one sensor, where thecontroller is adjustable to vary a current through the at least one coilso as to adjust the magnetic field focused upon the target nerve.
 2. Thesystem of claim 1 wherein the housing comprises a flexible wrap, acradle, or a garment.
 3. The system of claim 1 further comprising atleast one additional conductive coil disposed within or along thehousing.
 4. The system of claim 3 wherein each of the coils overlaprelative to one another.
 5. The system of claim 1 wherein the at leastone coil is movable within or along the housing to reposition themagnetic field relative to the target nerve.
 6. The system of claim 1wherein the at least one sensor is comprised of a patch applied to askin surface in proximity to the target nerve.
 7. The system of claim 1wherein the controller is adjustable independently of the at least onesensor.
 8. The system of claim 1 wherein the controller is adjustablevia a user.
 9. The system of claim 8 wherein the user comprises apatient or physician.
 10. The system of claim 1 wherein the controlleris configured to vary amplitude, frequency, direction of the magneticfield, or firing sequence of the at least on coil.
 11. A method ofmagnetic induction therapy, comprising: positioning a first portion of apatient's body relative to a housing such that a target nerve within thefirst portion of the body is in proximity to at least one conductivecoil disposed within or along the housing; passing a current through theat least one coil to generate a magnetic field focused on the targetnerve; detecting electrical conduction through the target nerve via atleast one sensor positioned along a second portion of the body inproximity to the target nerve; receiving a signal from the at least onesensor indicative of the electrical conduction; and adjusting thecurrent via a controller in communication with the at least oneconductive coil.
 12. The method of claim 11 wherein positioningcomprises placing a foot, ankle, or leg relative to the housing.
 13. Themethod of claim 11 wherein passing a current comprises passing thecurrent through a plurality of coils to generate the magnetic field. 14.The method of claim 11 wherein detecting comprises detecting theelectrical conduction along the second portion of the body which isdifferent from the first portion of the body.
 15. The method of claim 11wherein adjusting comprises adjusting an amplitude, frequency, directionof the magnetic field, or firing sequence of the at least on coil. 16.The method of claim 11 wherein adjusting comprises adjusting a positionof the at least one coil relative to the first portion of the patientbody to re-focus the magnetic field on the target nerve.
 17. The methodof claim 11 wherein adjusting comprises varying the current according toa muscular response in the patient.
 18. The method of claim 11 whereinadjusting comprises manually adjusting the current by a patient orphysician.